The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guerin on the Quality of Life in Superficial Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus-Calmette Guerin (BCG) Instillation Therapy on the Quality of Life in Non-muscle-invasive Bladder Cancer (NMIBC) Patients: Results of a Prospective, Randomised Phase II Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697306
• Other study ID #: CE 70/06
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2012
• Last updated: September 27, 2012
• Start date: September 2006
• Est. completion date: May 2012

Study information

• Verified date: September 2012
• Source: Azienda Ospedaliera San Giovanni Battista
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines AgencyGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive (NMIBC) patients treated with BCG or gemcitabine.

Description:

Intravesical Bacillus Calmette-Guérin (BCG) is considered the most effective agent for non-muscle-invasive bladder cancer (NMIBC), representing the first-line option in the management of carcinoma in situ (CIS) and high-risk disease. In intermediate-risk NMIBC, however, both BCG and intravesical chemotherapy are accepted alternative adjuvant options since the superiority of BCG has been only established for disease recurrence but not progression and it needs to be balanced against higher toxicity. According to current evidence, BCG is considered less tolerable than intravesical chemotherapy such as mitomycin-C or doxorubicin, based on reported side effects. Among chemotherapeutic agents, gemcitabine has an excellent toxicity profile and promising efficacy in NMIBC patients, including those at high-risk of disease recurrence, even if its role on the management of NMIBC has not been well-defined yet. To our knowledge, there are no comparative studies on BCG and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk NMIBC patients treated with BCG or gemcitabine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• patients with clinical evidence of intermediate-risk non-muscle invasive bladder cancer (namely Ta-1, G1-2, multifocal or unique and recurrent, >3 cm in diameter)

• WHO performance status =2

• age =85years

• BCG naive

• patients not treated with intravesical chemotherapy in the last 3 months.

Exclusion Criteria:

• presence of T1G3 or CIS

• preoperative urinary cytology positive for high-grade atypia

• inadequate bone marrow reserve (white blood cells <3 x 109/l, platelets <100 x 109/l)

• history of genito-urinary tuberculosis

• presence of uncontrolled urinary infections.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Gemcitabine 2 g
six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline
• BCG Vaccine
six weekly instillations of Connaught strain BCG (Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline

Locations

Country	Name	City	State
Italy	A.O.U. San Giovanni Battista Molinette	Torino	TO

Sponsors (4)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Giovanni Battista	Universitätsklinikum Hamburg-Eppendorf, University of Eastern Piedmont, University of Turin, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Martínez-Piñeiro JA, Martínez-Piñeiro L, Solsona E, Rodríguez RH, Gómez JM, Martín MG, Molina JR, Collado AG, Flores N, Isorna S, Pertusa C, Rabadán M, Astobieta A, Camacho JE, Arribas S, Madero R; Club Urológico Español de Tratamiento Oncológico (CUETO). Has a 3-fold decreased dose of bacillus Calmette-Guerin the same efficacy against recurrences and progression of T1G3 and Tis bladder tumors than the standard dose? Results of a prospective randomized trial. J Urol. 2005 Oct;174(4 Pt 1):1242-7. — View Citation

Porena M, Del Zingaro M, Lazzeri M, Mearini L, Giannantoni A, Bini V, Costantini E. Bacillus Calmette-Guérin versus gemcitabine for intravesical therapy in high-risk superficial bladder cancer: a randomised prospective study. Urol Int. 2010;84(1):23-7. doi: 10.1159/000273461. Epub 2010 Feb 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG		1 year	Yes
Secondary	comparison of the short term efficacy of the two treatments in terms of recurrence		1 year	No
Secondary	comparison of the short term efficacy of the two treatments in terms of progression		1 year	No